1. Field of the Invention
The present invention is generally directed to an apparatus, method, and system for testing human olfactory sensory system functions. More particularly the present invention operates to provide a method for the precise generation of specified olfactory system testing odorants, for use in making standardized testing of olfactory systems, data collection, assessment, and predictive or diagnostic results, and even more particularly for human olfactory system odor detection, odor adaptation, odor discrimination and odor identification ability to identify disease or disorder(s) and as a predictive element of cognitive impairment.
2. Description of the Prior Art
A decrease in olfactory function with age has been attributed to a variety of factors, including normal anatomical and physiological changes in aging, trauma, environment, exposure to toxins, medications, and disease. A decrease in olfactory function has also been determined to be one of the best predictors of five-year survival. Other research shows that changes associated with diseases such as diabetes affects olfactory function. Cognitive disease or disorder, namely Alzheimer's disease, Parkinson's disease, traumatic brain injury, Amyotrophic lateral sclerosis (ALS) and schizophrenia, are known to be associated with olfactory dysfunction. In particular, the ability to identify and discriminate the odors, as well as the odor threshold, can be altered in cognitive disorders. These changes often occur as early manifestation of the cognitive pathology but they are not always diagnosed on time. Early diagnosis can lead to slowing, stopping, or reversing the progression of cognitive decline.
U.S. Pat. No. 6,059,724 for system for predicting future health by inventors Campell, et al. filed Feb. 14, 1997 and issued May 9, 2000 is directed to a computer-based system for predicting future health of individuals comprising a computer comprising a processor containing a database of longitudinally-acquired biomarker values from individual members of a test population; a computer program that includes steps for selecting from said biomarkers a subset of biomarkers for discriminating between members, and using the distributions of the selected biomarkers to develop a statistical procedure that is capable of being used for classifying members of the test population, and estimating quantitatively, for each member of the test population, the probability of acquiring the specified biological condition.
U.S. Pat. No. 6,325,475 for devices for presenting airborne materials to the nose by inventors Hayes, et al. filed Apr. 21, 1997 and issued Dec. 4, 2001 is directed to an ink-jet dispenser for the micro-dispensation of airborne materials into an individual's airspace for inhalation or sniffing. The ink-jet dispenser will allow the study of temporal integration times, inter-nostril summation, backwards and forwards masking, and other olfactory phenomena.
U.S. Pat. No. 6,338,715 for digital olfactometer and method for testing olfactory thresholds by inventors Hayes, et al. filed Mar. 31, 2000 and issued Jan. 15, 2002 is directed to a more reliable and precise method of determining the olfactory threshold is provided by a digitally operated apparatus that dispenses controlled amounts of a volatile test fluid from a digital jetting device of the type used for ink jet printing. A precise number and size of micro droplets are dispensed onto a heater which vaporizes the fluid at a test location where a patient can sniff and report whether the odor is sensed. Incremental adjustments are made to determine the approximate threshold of olfactory perception of the odor. Sensors are included to verify dispensing and to coordinate dispensing with breathing.
U.S. Pat. No. 6,557,394 for smell test device by inventor Doty filed Apr. 2, 2001 and issued May 6, 2003 is directed to a test for assessing a person's sense of smell and more particularly, toward a test which is easy to use and can be evaluated by the individual taking the test.
U.S. Pat. No. 8,429,950 for field olfactometer with differential flow-based dynamic dilution by inventor Wright filed Aug. 5, 2010 and issued Apr. 30, 2013 is directed to a low-cost field olfactometer that may be used to determine when an environmental odor is present in the ambient air in an amount which is at or above a predetermined dilution ratio. The invention also encompasses a method of olfactometry and a replaceable diluent filter cartridge assembly employed in the olfactometer and olfactometry method.
U.S. Pat. No. 8,469,293 for digital odor generator by inventors Doty, et al. filed Apr. 16, 2010 and issued Jun. 25, 2013 is directed to a digital odor generator or olfactometer and, more particularly, toward a digital odor generator that can be used to administer various odors alone or in various combinations to a patient or subject. The digital odor generator of the invention can also be used to administer olfactory tests remotely over the Internet or other network and to collect the results and tabulate data over such networks.
U.S. Pat. No. 8,820,265 for high-throughput operant sensory discrimination apparatus and method by inventors Palmer and Salemme filed Dec. 6, 2005 and issued Sep. 2, 2014 is directed to apparatus and systems useful in sensory discrimination. Through the use of a multi-well sample plate, the high-throughput analysis apparatus and method allow for rapid sensory discrimination of a large number of samples.
US patent application 2007/077,204 for olfactory identification tests for cognitive diseases and disorders by inventors Devanand, et al. filed Apr. 13, 2006 and issued Apr. 5, 2007 is directed to smell tests (odor identification tests) that are shorter that UPSIT, yet has a statistical sensitivity and specificity equivalent to or better than UPSIT. The odor identification tests of the invention are based on a core set of six odorants, where the six odorants can be selected from the following group of odorants: menthol, clove, leather, strawberry, lilac, pineapple, smoke, soap, natural gas and lemon. The invention provides odor identification tests that can: (1) discriminate between subjects who are normal and who have a neuropsychiatric condition, cognitive disease or disorder, and/or (2) predict which subjects with mild cognitive disorders will develop various neuropsychiatric conditions or cognitive diseases and disorders. In one embodiment, the test and methods of the invention can provide an early prediction or diagnosis of Alzheimer's disease that is important for patients (including patients who have mild cognitive disorders, such as MCI) and clinicians to make plans for the future and to institute early treatment.